While the American food supply is among the safest in the world, the federal government estimates that there are about 48 million cases of foodborne illness annually, or the equivalent of sickening 1 in 6 Americans each year.
Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to report when there is a reasonable probability that the use of, or exposure to, an article of food, will cause serious adverse health consequences or death to humans or animals.
Moreover, voluntarily reporting helps the U.S. Food and Drug Administration better protect the public health, by tracking patterns and targeting inspections.
For all questions or problems related to meat and poultry, please contact the United States Department of Agriculture (USDA).
If you are a consumer, health professional, or member of the food industry who wants to voluntarily report a complaint or adverse event (illness or serious allergic reaction) related to a food product, you have the following choices:
▪ Call the U.S. FDA (U.S. Food and Drug Administration) Consumer Complaint Coordinator, if you wish to speak directly to a person about your problem.
FDA 24-hour Emergency Number for Food-borne Illness: 301-443-1240.
Consumer Complaint Coordinators are assigned to a district which may include more than one state. Therefore, several states may have the same Consumer Complaint Coordinator assigned to them.
▪ Complete an electronic Voluntary MedWatch form online.
▪ Complete a paper Voluntary MedWatch form that can be mailed to FDA.
▪ If you are a member of the food industry who needs to submit a Reportable Food Registry report when there is a reasonable probability that an article of food will cause serious adverse health consequences or death to humans or animals, please visit the Reportable Food Registry page.
Consumers or health professionals who want to voluntarily report defects in the quality or safety of a dietary supplement or an adverse event (illness or serious allergic reaction) related to a dietary supplement, can visit the Safety Reporting Portal.
If you are an industry member who needs to file a Mandatory Adverse Event Report about a dietary supplement as required by section 761 of the FD&C Act, please visit the Safety Reporting Portal.
However, if you need assistance or have any questions about reporting on dietary supplements, see Dietary Supplements – Reporting an Adverse Event for more information.
In fine, consumer product reports are an important part of FDA’s monitoring system, and help ensure that the products the agency regulates are safe, properly manufactured and stored, and correctly labeled.
Timely reporting by consumers, health professionals, and FDA-regulated companies allows the agency to take prompt action. Upon completion of the report, you will be presented with a confirmation page that includes an Individual Case Safety Report ID (ICSR). The ICSR is your official confirmation that FDA or NIH has received your completed report.
